Label: PROVIDA OB- prenatal multivitamin mineral supplement enhanced with lactobacillus casei ke-99 capsule

Other Ingredients: Titanium Dioxide, FD&C Blue #1, FD&C Red #40, Hypromellose, Magnesium Stearate and Microcrystalline Cellulose.

INDICATIONS: Provida OB™ is a prenatal supplement designed to improve the nutritional status of women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Provida OB™ may also be used to improve the nutritional status of women before conception.

CONTRAINDICATIONS: Provida OB™ is contraindicated in patients with a known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. It is also contraindicated in patients suffering from pernicious anemia as folic acid may obscure its signs and symptoms.

Ferrous Fumarate and Polysaccharide Iron Complex (PIC): All Provida products include a unique patented source of iron, e.g. Ferrous Fumarate and Polysaccharide Iron Complex (U.S. Patent No: 11/243,043 Pending). "An increase in tolerability is observed with the formulation and is believed to occur as the result of distributing the total iron content in the composition among compounds that provide iron to the patient's blood stream via two different mechanisms. The ferrous salts are readily absorbed in the upper gut, by direct dissolution and absorption of the ferrous iron by the bloodstream. However, the iron available from PIC is absorbed in the lower gut, via an active protein transport mechanism".

Clinical Studies: Picinni, L.-Ricciotti, M. 1982. Therapeutic effectiveness of an iron-polysaccharide complex in comparison with iron fumarate in the treatment of iron deficiency anemias: PANMINERVA MEDICA-EUROPA MEDICA, Vol. 24, No. 3, pp. 213-220 (July-September 1982).

Folic Acid: Folic Acid is one of the important hematopoietic agents necessary for proper regeneration of the blood-forming elements and their function. Additionally, folic acid increases jejunal glycolytic enzymes and is involved in the desaturation and hydroxylation of long-chain fatty acids in the brain. A deficiency in folic acid results in megaloblastic anemia.

WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

PRECAUTIONS: Folic acid in doses above 0.1 mg - 0.4 mg daily may obscure the signs and symptoms of pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive. The use of this product by immunocompromised patients or treatment of any disorder must be medically supervised by a physician.

OVERDOSE: Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300-mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted.

DOSAGE AND ADMINISTRATION: Adults (persons over 12 years of age), one (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.

HOW SUPPLIED: Provida OB™ are swedish orange opaque Vcaps® capsules printed in white "US" Logo on the cap and “ProV” on the body. Packed in child resistant cap and light resistant bottle of 30 capsules (52747-0504-30). The listed product number is not a National Drug Code. Instead, US Pharmaceutical Corporation has assigned this product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

CAUTION: Rx only.

Prenatal Multivitamin & Mineral Supplement enhanced with Lactobacillus casei KE-99

Consult package literature for full prescription information. You should contact your healthcare provider for medical advice about adverse events. To report a serious adverse event, contact US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036. Marketed by US Pharmaceutical Corporation. Manufactured with Vcaps® Plus capsule shells. Store at room temperature 15° to 30°C (59° to 86°F) and dry place. Manufactured in a FDA registered facility in the USA.

Rev. 09/2022

Patent Numbers: USA: 6,797,266; 5,626,883; Mexico MX/a/2008/004461; Singapore: 200802623-9 and other countries. Vcaps® and the Vcaps® Logo are trademarks used under license.